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FDAOctober 22, 2021device

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorpor...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

What to do

FDA enforcement status: Ongoing

Brands named

atrium medicalatrium

UPCs

00650862100211

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorpor... — Recall Details · AllClear